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Biomedical (Biomed) Refresher 2

This course provides retraining on the HSR Biomed Basic course and discusses core human subjects research topics for biomedical researchers.


About this Course


This Refresher 2 course reviews key issues from the Human Subjects Research – Biomedical (Biomed) Basic course. It expands on topics covered in the basic course through summarizing the most important points from the foundational basic course. It also provides in-depth condensed retraining for human subjects protections.

It should be completed after learners complete the first refresher course in this series, Human Subjects Research – Biomedical (Biomed) Refresher 1 course. It is generally recommended that organizations select refresher content requirements that reflect their selections for the basic course(s). Refresher courses should be taken in a cycle at an interval specified by your organization (for example, Refresher Stage 1: 3 years after completion of basic course; Refresher Stage 2: 6 years after completion of basic course).

Language Availability: English

Suggested Audiences: Researchers, Institutional Review Boards (IRBs), Institutional/Signatory Officials, IRB Chairs, IRB Administrators and Staff, Human Subject Protection Staff, Students

Organizational Subscription Price: Included in organizational subscription
Independent Learner Price: $110 per person


CE Credits and Units


To purchase CE credits and units, you need to be affiliated with an organization that subscribes to this course or buy it as an independent learner first.

Physicians

AMA PRA Category 1 Credit

3 Credits
(6 CE certified modules)
$50

6 Credits
(12 CE certified modules)
$75

1 September 2016
31 August 2019

Psychologists

CE Credit/Hour

3 Credits
(6 CE certified modules)
$50

6 Credits
(12 CE certified modules)
$75

1 September 2016
31 August 2019

Other Participants

Certificate of Participation

3 Credits
(6 CE certified modules)
$40

6 Credits
(12 CE certified modules)
$75

1 September 2016
31 August 2019


Course Content


Toggle Content Biomed Refresher 2 – Instructions

Provides instructions for the Biomed Refresher 2 course.

Recommended Use: Required
ID (Language): 764 (English)

Toggle Content Biomed Refresher 2 – History and Ethical Principles CME/CEU Badge

Describes the ethical principles of respect for persons, beneficence, and justice from the Belmont Report. Presents a case study with a discussion identifying the roles of the ethical principles. Provides refresher training for the basic modules History and Ethics of Human Subjects Research and Basic Institutional Review Board (IRB) Regulations and Process.

Recommended Use: Required
ID (Language): 511 (English)
Author(s): Elizabeth Bankert, MA - Dartmouth College; Jeffrey A. Cooper, MD - Huron Consulting Group, Inc.

Toggle Content Biomed Refresher 2 – Regulations and Process CME/CEU Badge

Summarizes the module Basic Institutional Review Board (IRB) Regulations and Review Process. Describes the regulatory definition of “research” as it applies to human subjects research and identifies the components of the definition “human subjects.”

Recommended Use: Required
ID (Language): 512 (English)
Author(s): Ada Sue Selwitz, MA - University of Kentucky; Janelle R. Erickson, MPH - Seattle BioMedical Research Institute

Toggle Content Biomed Refresher 2 – SBR Methodologies in Biomedical Research CME/CEU Badge

Reviews the module Social and Behavioral Research for Biomedical Researchers. Identifies the risks from non-biomedical research methods and some of the ways these risks can be minimized.

Note: It is recommended that this module be Required or Supplemental depending on the learner group.

Recommended Use: Required
ID (Language): 515 (English)
Author(s): Deborah Dickstein, MSPH - University of Washington; Celia Walker, MA - Colorado State University (ret.)

Toggle Content Biomed Refresher 2 – Records-Based Research CME/CEU Badge

Takes another look at the key issues presented in the module Records-Based Research. Identifies types of review that apply to records-based research and note examples of records-based research that are appropriate for the different levels of review.

Recommended Use: Required
ID (Language): 516 (English)
Author(s): Judy Matuk, MS - Stony Brook University

Toggle Content Biomed Refresher 2 – Genetics Research CME/CEU Badge

Discusses issues related to the consent process in genetic research, including re-contacting subjects. Also reviews some of the risks associated with genetic research that should be disclosed during the consent process. Provides refresher training for the module Genetic Research in Human Populations.

Recommended Use: Required
ID (Language): 518 (English)
Author(s): Jeffrey R. Botkin, MD, MPH - University of Utah

Toggle Content Biomed Refresher 2 – Populations in Research Requiring Additional Considerations and/or Protections CME/CEU Badge

Describes the elements of autonomy and its role in research. Discusses the relationship between autonomy and populations in research requiring additional considerations and/or protections. Reviews key concepts from the module Populations in Research Requiring Additional Considerations and/or Protections.

Recommended Use: Required
ID (Language): 519 (English)
Author(s): David Forster, JD, MA, CIP - Western IRB

Toggle Content Biomed Refresher 2 – Research Involving Prisoners CME/CEU Badge

Defines “prisoner” pursuant to 45 CFR 46 and discusses why prisoners need additional protections in research based on the basic module Vulnerable Subjects – Prisoners.

Note: It is recommended that this module be Required or Supplemental depending on the learner group.

Recommended Use: Required
ID (Language): 520 (English)
Author(s): Helen McGough, MA - University of Washington (ret.)

Toggle Content Biomed Refresher 2 – Research Involving Children CME/CEU Badge

Describes the various parental permission requirements associated with the different types of permitted research with children under 45 CFR 46, Subpart D. Identifies when child assent is also required and when it may be waived. Condenses essential topics covered in Vulnerable Subjects – Children.

Note: It is recommended that this module be Required or Supplemental depending on the learner group.

Recommended Use: Required
ID (Language): 521 (English)
Author(s): Bruce Gordon, MD - University of Nebraska Medical Center

Toggle Content Biomed Refresher 2 – Research Involving Pregnant Women, Fetuses, and Neonates CME/CEU Badge

Reviews the requirements for conducting research with neonates of uncertain viability pursuant to 45 CFR 46, Subpart B. Abridged version of Vulnerable Subjects – Pregnant Women, Human Fetuses, and Neonates.

Note: It is recommended that this module be Required or Supplemental depending on the learner group.

Recommended Use: Required
ID (Language): 522 (English)
Author(s): Bruce Gordon, MD - University of Nebraska Medical Center; Ernie Prentice, PhD - University of Nebraska Medical Center

Toggle Content Biomed Refresher 2 – Informed Consent CME/CEU Badge

Reviews the requirements for waiving or altering elements of informed consent and considerations for both IRBs and researchers to understand. Identifies the requirements for waiving the requirement for obtaining signed informed consent forms (documentation). Summarizes key points from Informed Consent.

Note: It is recommended that this module be Required or Supplemental depending on the learner group.

Recommended Use: Required
ID (Language): 514 (English)
Author(s): Diane Paul, MS, RN - Drug Development Associates, LLC

Toggle Content Biomed Refresher 2 – FDA-Regulated Research CME/CEU Badge

Summarizes the module FDA-Regulated Research. Reviews when an Investigational New Drug (IND) application is needed or not, including reviewing when a substance is considered a “drug” by the federal regulations.

Note: It is recommended that this module be Required or Supplemental depending on the learner group.

Recommended Use: Required
ID (Language): 524 (English)
Author(s): Susan Kornetsky, MPH - Boston Children's Hospital

Toggle Content Biomed Refresher 2 – HIPAA and Human Subjects Research CME/CEU Badge New/Updated Badge

Discusses situations where HIPAA requires consent for research activities, and those that can qualify for waivers, alterations, or exemptions from that requirement. Based on the basic module Research and HIPAA Privacy Protections.

Note: It is recommended that this module be Required or Supplemental depending on the learner group.

Recommended Use: Required
ID (Language): 526 (English)
Author(s): Reid Cushman, PhD
 - CITI Program

Toggle Content Biomed Refresher 2 – Conflicts of Interest in Human Subjects Research New/Updated Badge

Identifies federal regulations that govern disclosure of individual COIs and discusses when individual significant financial interests in research may be considered COIs.

Recommended Use: Required
ID (Language): 17545 (English)
Author(s): Julie Moore, JD, MS, PA, CIP - University of South Florida; Cristy McGoff, MA - Harvard University